SmartBinge: Smartphone Application for University Students With Binge Drinking Behavior

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Recruiting

CT.gov ID

NCT06084832

Collaborator

EPSM Marne, Reims (Other), SCA-LAB UMR-CNRS 9193, Lille (Other), Paul Valery University, Montpellier (Other)

628

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Alcohol use is a causal factor in more than 200 diseases and injury conditions (see ICD-10) and in France, alcohol is the first cause of hospitalization. Binge drinking (BD) has emerged as a major public health issue among student populations and is associated with negative consequences and social, cognitive and brain alterations. More than half of French university students have reported BD in the past month and are at increased risk of several alcohol-related consequences such as memory and sleep impairments, and reduced quality of life. BD is also a major risk factor in the development of alcohol addiction, with individual and environmental factors playing a role that is still poorly understood. Moreover, most students and young adults are reluctant to seek interventions when it is provided by health care professionals (only 4-5%) and have poor insight with regard to their alcohol use patterns / habits. Thus, there is an urgent need for developing effective prevention and intervention programs to reduce alcohol drinking in students. Recent studies have demonstrated that new types of technology-delivered interventions are promising tools for addressing unhealthy alcohol use. For example, an uncontrolled trial pilot study using a smartphone application-delivered intervention produced a reduction in both number of drinks per week and BD from baseline to 3-month follow-up. A recent review also showed significant outcomes of a mobile health intervention for self-control of unhealthy alcohol use. The investigators hypothesize that a timeline follow-back and personalized feedback based on the use of a mobile application can reduce excessive alcohol intake at 3-months. This study will provide scientific knowledge about BD in students, but also regarding a new type of intervention that could be effective for prevention in non-treatment seeking individuals and reducing the severity of health problems associated with excessive alcohol intake.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Drinking Binge Drinking	Biological: blood microsampling	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

628 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

Official Title:

Smartphone Application for University Students With Binge Drinking Behavior: National Randomized Controlled Trial

Actual Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2026

Anticipated Study Completion Date :

Jul 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Binge Drinking	Biological: blood microsampling blood microsampling for the measure of Phosphatidylethanol
Active Comparator: Binge Drinking-control	Biological: blood microsampling blood microsampling for the measure of Phosphatidylethanol

Arm

Intervention/Treatment

Experimental: Binge Drinking

Biological: blood microsampling

blood microsampling for the measure of Phosphatidylethanol

Active Comparator: Binge Drinking-control

Biological: blood microsampling

blood microsampling for the measure of Phosphatidylethanol

Outcome Measures

Primary Outcome Measures

Change of the number of standard drinks per week [30 months]

Secondary Outcome Measures

Change of the PEth concentration [3 months]
phosphatidylethanol (PEth)
Change of the PEth concentration [6 months]
phosphatidylethanol (PEth)
Change of the PEth concentration [9 months]
phosphatidylethanol (PEth)
Change of the PEth concentration [12 months]
phosphatidylethanol (PEth)
Change of the PEth concentration [15 months]
phosphatidylethanol (PEth)
Change of the PEth concentration [18 months]
phosphatidylethanol (PEth)
Change of the PEth concentration [21 months]
phosphatidylethanol (PEth)
Change of the PEth concentration [24 months]
phosphatidylethanol (PEth)
Change of the PEth concentration [27 months]
phosphatidylethanol (PEth)
Change of the PEth concentration [30 months]
phosphatidylethanol (PEth)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 25 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Students between 18 and 25 years old
AUQ score greater than or equal to 24, and AUDIT score greater than or equal to 3 for its first 3 items. Drinking details with the DDQ when necessary.
BD behavior: at least one occasion with 6 or more drinks in the last 3 months.
Consent to be included in the study
Affiliated to social security